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Vertex Pharmaceuticals Incorporated Message Board

  • emserm emserm Oct 23, 2006 3:00 PM Flag

    S&P MAINTAINS STRONG BUY OPINION ON SHARES OF VERTEX PHARMACEUTICALS

    An FDA panel recommended that sustained viral response should be measured at 24 weeks after the end of HCV therapy and that shortening the duration of therapy over the standard of care is unlikely to lead to approval of the VX-950 hepatitis C treatment, unless superiority of efficacy is also shown. Also, a 72-week control arm might be required, which could extend the filing date. We see some risk to the clinical timeline. However, we remain positive on VRTX and view the shares as compelling at current levels. Our 12-month target price remains $42.

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    • CORRECTION.

      A 72-wk control arm must mean a 48-wk SOC + a 24-wk period for SVR determination. This is reasonable.

      For Ph III trial, a trial arm for 12-wk 950 + 36-wk additional SOC might be all needed then. That does not delay the program much.

    • Thanks, emsem, for posting lots of useful information.

      The passage: " ... Also, a 72-week control arm might be required, which could extend the filing date. We see some risk to the clinical timeline..."
      brought us down here from 37 area.

      A 72-week control arm is irrational if control arm is the IFN+RBVN standard of care. How many patients can withstand such a long torture!

      From the front part of the SP passage, see that FDA thinking is that a short trial is OK if the efficacy is good.

      If 24-wk SVR is 75%, don't see who would dare demand 2 year IFN.

      I predict that SVR for patient with genotype 1 would be better than 83% with 950. This figure comes from the rate of hard-to-treat mutant occurance.

 
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